5. NEED STATEMENT DEVELOPMENT (Based on a lecture by Andrew DiMeo)
5 Min.
30 Min.
In 1997, the FDA published Design Control Guidance for Medical Device Manufacturers, advising businesses to control design. It was meant to convey that product success depends on design. As of 2010, academic and hospital-based organizations started to focus in translating their innovation and today we're seeing more ideas from universities and hospitals. This is a substantial change from the 1997 guidance document that was to guide medical device manufacturers. Academic innovators lack design control guidelines, so many don't know about it or don't execute it because it's hard. Leaving design history in the rearview mirror can haunt us, so take care of it today to make the journey ahead smoother. Our industry misrepresents the FDA's waterfall diagram as a stage-gate process. However, user needs may not occur in a stage-gate-like process. • We must establish unmet requirements iteratively since products evolve. This evolutionary real-life medical device design method can help us define user needs in a way that saves time and improves our product. A Harvard Business School lecturer remarked, "Fall in love with the problem, not the solution”. The problem with outcome-driven innovation is forcing in the outcome before we understand the problem that really needs solving. We encourage you to read Lance Bettencour, Clayton Christensen, Tony Ulwick, or Don Norman. They all recognize that we need to understand the problem before discussing solutions. Needs and solutions are relative to each other and relative to individual perspectives. "Users don't need a quarter-inch drill, what they need is a quarter-inch hole." The hypothetical mind experiment says we need the hole to access the brain, to remove a tumor, to improve the quality of life. However, since drilling produces the hole, we claim we need the hole to enter the brain, remove a tumor, and improve life.
8 | P a g e
Made with FlippingBook Ebook Creator